CLINICAL TRIALS, STUDIES, REGISTRIES, DATA

SELUTION DeNovo Study is the largest DEB study ever initiated, involving up to 70 participating sites across 15 countries. Patients are randomized before any vessel preparation to reflect current medical practice and to reduce bias.  The objectives of the study are to demonstrate non-inferiority at both one and five years, and superiority for target vessel failure (TVF) at five years.

Vitestro expects to obtain CE marking by the end of 2024. The first 350 patients have currently been enrolled the A.D.O.P.T. (Autonomous Optimization and Performance Tests for Blood Testing) Trial at study site Result Laboratorium in the Albert Schweitzer Hospital. Investigational partners, in addition to Result Laboratorium - Albert Schweitzer Hospital, are St. Antonius, OLVG Lab and Amsterdam UMC.

The aim of the LOVE-DEB Study (Large de-NOVo coronary artEry disease treated with sirolimus Drug Eluting Balloon: prospective evaluation of safety & efficacy of SELUTION SLR drug eluting balloon) is to evaluate the safety and efficacy of SELUTION SLR in treating native de novo coronary artery disease in larger vessels (≥2.75mm). Its primary objective is to evaluate the proportion of patients who underwent Target Lesion Revascularization (TLR) within one year of their procedure.

“Gaining validation from the DSMB for the continued implementation of our proof-of-concept study is significant for SynerFuse, and we are thrilled about this milestone,” said SynerFuse co-founder, president, and CEO Justin Zenanko.

"The PINNACLE Clinical Trial Study: A Double-blind, Randomized, Sham-controlled Study Evaluating the Optilume BPH Catheter System for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia," was authored by Dr. Steven A. Kaplan, professor of urology at the Icahn School of Medicine at Mount Sinai in New York and the principal investigator of the PINNACLE study.

The extended agreement covers any European country. The company has signed summary distribution agreements with Innovimed in Poland, Czech Republic, and Slovakia, subject to completion of product development and regulatory approval, potentially generating over $130 million in revenues for the Company over seven years.

“Dravet syndrome is a rare and devastating form of childhood epilepsy in which there is an unmet need for patients whose seizures remain difficult to control and who experience significant side effects with current medications,” said Paolo Baroldi, PhD, MD, Chief Medical Officer of Bloom Science. “BL-001 shows promise as a novel treatment option that can change lives. With these results we plan to proceed into Phase 2 clinical development with doses we expect to be within the therapeutic window in both Dravet syndrome and ALS.”

"The 24-month data from the SENZA-PDN RCT show us high-frequency SCS is a viable, long-term relief solution for people with PDN, which is particularly encouraging for a condition that naturally worsens over time," said lead Principal Investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. "These results further validate not only the efficacy of high-frequency 10 kHz SCS for pain relief, but also show profound improvements in quality of life, sleep, and neurological function."